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AIDS and Behavior

, Volume 21, Issue 12, pp 3336–3345 | Cite as

Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men

  • Alex Carballo-Diéguez
  • Rebecca Giguere
  • Curtis Dolezal
  • Cheng-Shiun Leu
  • Iván C. Balán
  • William BrownIII
  • Christine Rael
  • Barbra A. Richardson
  • Jeanna M. Piper
  • Linda-Gail Bekker
  • Suwat Chariyalertsak
  • Anupong Chitwarakorn
  • Pedro Gonzales
  • Timothy H. Holtz
  • Albert Liu
  • Kenneth H. Mayer
  • Carmen D. Zorrilla
  • Javier R. Lama
  • Ian McGowan
  • Ross D. Cranston
  • On Behalf of the MTN-017 Protocol Team
Original Paper

Abstract

Oral pre-exposure prophylaxis (PrEP) can prevent HIV transmission. Yet, some may prefer not to take systemic daily medication. MTN-017 was a 3-period, phase 2 safety and acceptability study of microbicide gel applied rectally either daily or before and after receptive anal intercourse (RAI), compared to daily oral tablet. At baseline, cisgender men and transgender women who reported RAI (N = 187) rated the daily oral regimen higher in overall liking, ease of use, and likelihood of future use than the gel regimens. After trying all three, 28% liked daily oral the least. Gel did not affect sexual enjoyment (88%) or improved it (7–8%). Most partners had no reaction to gel use. Ease of gel use improved significantly between the first and the last few times of daily use. A rectal gel used before and after RAI may constitute an attractive alternative to daily tablet. Experience with product use may increase acceptability.

Keywords

Acceptability Gel PrEP Microbicide Rectal 

Resumen

La profilaxis pre-exposición oral (PrEP) puede prevenir la transmisión del VIH. Sin embargo, algunos individuos pueden preferir no tomar un medicamento sistémico diariamente. MTN-017 fue una investigación fase dos con tres períodos para evaluar la seguridad y aceptabilidad de un gel microbicida aplicado por vía rectal, ya sea diariamente o antes y después del sexo anal receptivo (SAR), comparado con una tableta oral diaria. Al inicio del estudio, los participantes hombres y mujeres transgénero que reportaron SAR (N = 187) dieron calificaciones más altas al régimen oral diario que a los regímenes de gel en cuanto a agrado en general, facilidad de uso, y probabilidad de uso futuro. Pero después de probar los tres regímenes, a 28% de los participantes le gustó menos la tableta diaria. El gel o bien no afectó al placer sexual (88%) o lo mejoró (7-8%). La mayoría de las parejas no tuvo ninguna reacción al uso del gel. La facilidad del uso del gel mejoró significativamente entre los primeros y los últimos usos del gel diario. Un gel rectal usado antes y después del SAR puede ser una alternativa atractiva a una tableta diaria. La experiencia con el uso del producto puede mejorar la aceptabilidad.

Notes

Acknowledgements

We would like to thank the study participants for their participation and dedication and the study team members at the research sites, the protocol management team and the MTN leadership operations center for their contributions. We are grateful to Gilead Sciences who provided the FTC/TDF and CONRAD for providing RG-TFV.

Disclaimer

The content is solely the responsibility of the authors and does not necessary represent the official views of the National Institute of Health. The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors’ affiliated institutions. Use of trade names is for identification only and does not imply endorsement by the Public Health Service or by the U.S. Department of Health and Human Services.

Funding

The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health, to the Microbicide Trials Network. The HIV Center for Clinical and Behavioral Studies is funded by NIH Center grant P30 MH43520 (PI: Remien). William Brown III was supported by the National Library of Medicine (R01-LM012355-01A1, PI: Schillinger; and T15-LM007079, PI: Hripcsak), National Institute of Mental Health (P60-MD006902, PI: Bibbins-Domingo).

Compliance with Ethical Standards

Conflicts of interest

All authors declare they have no conflicts of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2017

Authors and Affiliations

  • Alex Carballo-Diéguez
    • 1
    • 15
  • Rebecca Giguere
    • 1
  • Curtis Dolezal
    • 1
  • Cheng-Shiun Leu
    • 1
  • Iván C. Balán
    • 1
  • William BrownIII
    • 1
    • 2
    • 3
  • Christine Rael
    • 1
  • Barbra A. Richardson
    • 4
  • Jeanna M. Piper
    • 5
  • Linda-Gail Bekker
    • 6
  • Suwat Chariyalertsak
    • 7
  • Anupong Chitwarakorn
    • 8
  • Pedro Gonzales
    • 9
  • Timothy H. Holtz
    • 8
    • 10
  • Albert Liu
    • 11
  • Kenneth H. Mayer
    • 12
  • Carmen D. Zorrilla
    • 13
  • Javier R. Lama
    • 9
  • Ian McGowan
    • 14
  • Ross D. Cranston
    • 14
  • On Behalf of the MTN-017 Protocol Team
  1. 1.HIV Center for Clinical and Behavioral Studies at New York State Psychiatric InstituteColumbia UniversityNew YorkUSA
  2. 2.Department of Medicine, Center for AIDS Prevention StudiesUniversity of California San FranciscoSan FranciscoUSA
  3. 3.UCSF Center for Vulnerable Populations, Health Communications Research ProgramZuckerberg San Francisco General HospitalSan FranciscoUSA
  4. 4.Department of BiostatisticsUniversity of WashingtonSeattleUSA
  5. 5.Division of AIDSNational Institute of Allergy and Infectious DiseasesRockvilleUSA
  6. 6.Desmond Tutu HIV CentreUniversity of Cape TownCape TownSouth Africa
  7. 7.Research Institute for Health SciencesChiang Mai UniversityChiang MaiThailand
  8. 8.Thailand Ministry of Public Health – U.S. Centers for Disease Control and Prevention CollaborationNonthaburiThailand
  9. 9.Asociación Civil Impacta Salud y EducaciónLimaPeru
  10. 10.U.S. Centers for Disease Control and PreventionAtlantaUSA
  11. 11.San Francisco Department of Public HealthSan FranciscoUSA
  12. 12.The Fenway Institute, Harvard Medical SchoolBeth Israel Deaconess Medical CenterBostonUSA
  13. 13.Department of Obstetrics and GynecologyUniversity of Puerto Rico School of MedicineSan JuanUSA
  14. 14.School of MedicineUniversity of PittsburghPittsburghUSA
  15. 15.Unit 15, New York State Psychiatric InstituteNew YorkUSA

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